EMA TO REVIEW CANAGLIFLOZIN OVER AMPUTATION RISKS

摘要

The European Medicines Agency (EMA) has announced that it is reviewing diabetes drug canagliflozin after a clinical trial found it may increase the rate of lower limb amputations. The incidence of amputation in the 4,300-patient Canagliflozin Cardiovascular Assessment Study (CANVAS) is currently 7 in 1,000 patient-years in those treated with canagliflozin 100mg daily and 5 in 1,000 in the 300mg daily group. This compares with a rate of 3 in 1,000 patient-years in the placebo group. The patients have so far been followed up for an average of 4.5 years.